Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning

This study has been completed.

Sponsor:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00611975

First Posted: February 11, 2008

Last Update Posted: June 28, 2012

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Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.

Other Name: Prozac, Serafem

Experimental: B

Participants will receive treatment with bupropion for 2 months

Drug: Bupropion

Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.

Other Name: Wellbutrin, Zyban

Detailed Description:

Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects.

Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months.

Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 45 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry

Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study

Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal IUD, partner with vasectomy) for the duration of the study

Exclusion Criteria:

Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels

Body mass index (BMI) greater than 30

Elevated testosterone at screening

History of seizure disorder

Consumes more than 10 alcoholic beverages per week

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611975

Sponsors and Collaborators

Weill Medical College of Cornell University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Margaret Altemus, MD

Weill Medical College of Cornell University

More Information

Responsible Party:

Margaret Altemus, Associate Professor, Weill Medical College of Cornell University